Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism

NCT ID: NCT06773533

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-18

Study Completion Date

2039-12-31

Brief Summary

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Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.

Detailed Description

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Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.

Inclusion in the registry will be proposed consecutively to every patient with adjuvant hormone-blockade breast cancer diagnosed and evaluated at the Endocrinology Operative Unit for Bone Mineral Metabolism as part of the 'Diagnostic Clinical-Assistance Pathway (PDTA) of the patient with breast cancer' of IRCCS AOU of Bologna and referred/referred by Zamagni Oncology. The registry will include patients seen from 01/01/2015 for a duration of 15 years. A maximum follow-up duration for each patient is expected to be 10 years with an end date of enrollment on 12/31/2029 and a registry update deadline on 12/31/2039.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patient undergoing adjuvant hormone blockade therapy (aromatase inhibitors, GnRH analogs, tamoxifen) for breast cancer referred by UO Oncology Zamagni
* Performed densitometry at UO Radiology Lovato and performed hematochemical tests inherent to mineral metabolism
* Informed consent obtained

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uberto Pagotto, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Uberto Pagotto, MD

Role: CONTACT

+390512144190

Facility Contacts

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Uberto Pagotto, MD

Role: primary

+390512144190

Uberto Pagotto, MD

Role: backup

Other Identifiers

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Als-BONE

Identifier Type: -

Identifier Source: org_study_id

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